Transcatheter Mitral and Tricuspid Interventions: a Cardiac Magnetic Resonance Study

NCT07370467 | Not Yet Recruiting

• 1 other identifier: L2-273
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Mitral and tricuspid valve disease represents an increasing challenge in the management of patients with heart failure and other cardiovascular diseases. In recent years, the introduction of transcatheter techniques for valve repair and replacement (TVI) has revolutionised the treatment of these diseases, particularly for patients at high surgical risk or who are not candidates for traditional surgery. However, although these procedures are increasingly popular, their long-term effectiveness in terms of cardiac remodelling is still not well understood. Cardiac magnetic resonance (CMR) techniques, with their advanced capabilities to provide anatomical and functional details of the heart, offer a unique opportunity to assess ventricular remodelling and valve function before and after transcatheter interventions. The ESC guidelines on valvulopathies published in 2021 recommend the use of cardiac magnetic resonance imaging not only to quantify the extent of mitral and tricuspid regurgitation when echocardiography is inconclusive, but also as the gold standard for the assessment of left and right ventricular size and function (limited, however, to the availability of this method in the various centres). Currently, there are few systematic data evaluating the effect of these procedures on CMR-assessed cardiac anatomy and function. This study aims to fill this gap by creating a multicentre registry in which clinical and advanced imaging data, including 3D echocardiography and CMR, are collected to assess the impact of these therapies. Analysis of data derived from advanced imaging will not only provide a better understanding of the mechanism of operation of transcatheter techniques, but will also provide important information for improving long-term patient outcomes by identifying potential predictors of treatment success or failure.

Conditions

Mitral Insufficiency; Transcatheter Aortic Valve Replacement

Outcome Measures

Primary Outcomes (1)

• Cardiac Remodelling

  Assessing the impact of mitral and tricuspid transcatheter procedures on cardiac remodelling.

  12 months

Secondary Outcomes (1)

• Analize imaging data

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients who are candidates for transcatheter treatment of severe mitral or tricuspid insufficiency

You may qualify if:

• Age ≥ 18 anni
• Signing informed consent
• Patients who are candidates for transcatheter mitral or tricuspid surgery (TEER, TTVR).

You may not qualify if:

• Age \< 18 years
• Contraindications to CMR or administration of contrast medium (gadolinium)

Sponsors & Collaborators

• Centro Cardiologico Monzino: lead
• Hospital Álvaro Cunqueiro: collaborator
• Centro Hospitalar de Vila Nova de Gaia/Espinho: collaborator

Study Sites (1)

Centro Cardiologico Monzino

Milan, Milan, 20131, Italy

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Gianluca Pontone, MD

CONTACT

0258002574; gianluca.pontone@cardiologicomonzino.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: January 27, 2026
• Study Start: January 30, 2026
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: January 27, 2026

Record last verified: 2025-01

Locations

IT (1)